Orthodontic wire alignment system and method

ABSTRACT

Disclosed is a system and method for treating mal-alignment of teeth using super-elastic nickel titanium, heat activated nickel titanium coated or uncoated orthodontic wires with composite resins in order to effectuate desired tooth alignment. The composite resin is formed into beads that hold the wire in place preferably on the lingual surface of the teeth. Alternate embodiments using composite brackets are disclosed. The overall purpose of this invention is to provide a close contact, low profile orthodontic system, in particular, a lingual orthodontic system that is significantly more comfortable than existing orthodontic systems, completely concealed and effective.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation of application Ser. No. 14/244,985filed on Apr. 4, 2014, entitled Orthodontic Wire Alignment System andMethod, which in turn claims priority from Provisional Application Ser.No. 61/808,953, filed on Apr. 5, 2013, entitled Coated Orthodontic WireAlignment System and Method.

FIELD OF INVENTION

The present invention relates to the field of orthodontics. Morespecifically, the present invention relates to systems and methods fortreating mal-alignment of teeth using super-elastic nickel titanium,heat activated nickel titanium coated or uncoated orthodontic wires withcomposite resins in order to effectuate desired tooth alignment.

BACKGROUND OF THE INVENTION

Orthodontic treatment is a specialty of dentistry that focuses on thetreatment of dental displacement and mal-alignment or misalignment ofteeth. Comprehensive orthodontic treatment most commonly involves theuse of metal wires that are inserted into orthodontic brackets, whichcan be made from stainless steel or ceramic materials. The metal wiresinteract with the brackets to exert continual force on the teeth togradually urge the teeth toward their intended positions.

More recently, alternatives to conventional orthodontic treatment withtraditional braces have become available. For example, systems includinga series of preformed appliances/aligners have become commerciallyavailable from Align Technology, Inc., San Jose, Calif., under the tradename Invisalign® System. The Invisalign® System is described in numerouspatents and patent applications including, for example in U.S. Pat. No.6,450,807, and U.S. Pat. No. 5,975,893, as well as on the company'swebsite, which is accessible on the World Wide Web (see, e.g., the urlinvisalign.com”). The Invisalign® System includes designing and/orfabricating multiple, and sometimes all, of the aligners to be worn bythe patient before the aligners are administered to the patient and usedto reposition the teeth (e.g., at the outset of treatment). Often,designing and planning a customized treatment for a patient makes use ofcomputer-based 3-dimensional planning/design tools, such as Treat™software from Align Technology, Inc. The design of the aligners relieson computer modeling of the patient's teeth in a series of plannedsuccessive tooth arrangements, and the individual aligners are designedto be worn over the teeth, such that each aligner exerts force on thetooth and elastically repositions the teeth to each of the planned tootharrangements.

Another orthodontic option is disclosed in U.S. patent application Ser.No. 13/470,681 to Li et al., also assigned to Align Technology.Disclosed is multilayer orthodontic positioning appliance which includesa removable orthodontic tooth positioning appliance having teethreceiving cavities shaped to directly receive at least some of thepatient's teeth and apply a resilient positioning force to the patient'steeth. The multilayer appliances can include a hard polymer layerdisposed between two soft polymer layers. The orthodontic treatmentprovides improved material performance, stress relaxation properties anda longer working range.

An alternative orthodontic technology is the LingualWirelign® andWirelign® technique of Benjamin A. Cassalia, Chalfont, Pa., whichprovides a system to correct malalignment of teeth using wires alone(that is, without orthodontic brackets) for increased patient comfortand a look without visible “braces” or wires on the facial surface ofthe patient's teeth. The Wirelign® technique uses straight segments ofsuper-elastic metal wire, usually nickel titanium wire, adhered tosurfaces of teeth—usually the lingual surface (i.e. the inside surfacesof teeth, as opposed to the front, facial surfaces)—to align teeth.

In certain cases after the use of currently available orthodonticmethods for correcting misaligned teeth, the alignment of teeth isimproved but the proper arch form may not be obtained. For example,sometimes as teeth are pulled or pushed into alignment, undesirabletooth movements may occur, resulting in an improper arch form. Onereason for certain undesirable tooth movements is that wires typicallyare bonded to each tooth individually at a fixed distance apart and donot permit the teeth to move closer to one another as they are pushedand/or pulled into alignment. In some cases, mal-alignment of teeth maybe minor or of a type that is not easily corrected by currentorthodontic procedures alone. And in some cases, continued treatment isdesired to maintain or improve proper arch form.

Therefore, there is a need in the art for an orthodontic wire alignmentsystem and method that provides improved arch form and continuedalignment of teeth when used alone or after use of other orthodontictechniques, that does so in an aesthetically and cosmetically pleasingway, and is comfortable to the wearer (referred to interchangeablyherein as the “patient”). The present invention provides an orthodonticsystem and method that is a comfortable, cosmetically pleasing means ofmaintaining or improving optimal arch form when used alone or after useof other orthodontic procedures.

The orthodontic system and method of the invention provide a number ofadvantages over previously available systems and methods. The placementof the coated wire directly to the surface of the tooth and theplacement of flowable bonding material over the wire create a lowprofile smooth surface system compared to typical orthodontic systemsthat use brackets with increased profile and distance of the wire fromthe tooth. The smooth surface of the bonding material used in theinvention compared to other brackets system with extended wings or doorsminimizes irritation and discomfort to the surrounding oral tissues. Thepresent system and method increase the effectiveness of tooth movementas a result of the close proximity of the wire to the tooth and thepotential formation of an orthodontic tube along the entire surface ofthe tooth. These two factors provide and increase engagement of thetooth surface and therefore enable more effective tooth movement, andespecially rotational movement of a tooth.

The present system also provides reduced speech related problems ascompared to the prior art. The reduced profile and resulting smoothsurface of the material used in the invention is comparable to alreadyused fixed lingual retainer systems which have little to no effect oftongue manipulation and speech related problems. Furthermore, becausethe orthodontic system of the invention is placed preferably on thelingual surface of the teeth and has low profile characteristics, theorthodontic system of the invention is essentially completely concealedor undetected by observers. A further advantage of the system of theinvention is its ease of application. The delivery system of theorthodontic system of the invention is designed for easy clinicalapplication of the coated wire and, as such, also provides improvedisolation from contaminants from the oral environment of the mouth.

One object of this invention is to improve the arch form obtained afteralignment of the teeth using known orthodontic techniques. By “arch”form as used herein is meant the arch derived by the alveolar process onthe jaw containing the dental anatomy of the teeth. The invention alsomay be used alone to correct mal-alignment of teeth if minimal tomoderate tooth movement is required. The design of the arch wire systemof the invention allows for the continuation of treatment for misalignedteeth using wires alone (that is, without bulky brackets or fixtures)for increased patient comfort. The wire is preferably affixed to thelingual surface of teeth such that it is not visible when the wearersmiles, thus providing a cosmetic benefit as compared to traditionalorthodontic appliances or retainers. Also within the scope of theinvention is use of the system of on the facial surface of teeth, albeitsuch use provides a lesser cosmetic advantage than use on the lingualsurface of the teeth. The term “facial” herein is used to mean“non-lingual”, as in the non-lingual surface of a tooth or teeth, andtherefore includes “labial” and “buccal”, as in the labial or buccalsurface of a tooth or teeth.

SUMMARY OF THE INVENTION

A coated orthodontic wire tooth alignment system and method is usedalone, after or in conjunction with known orthodontic techniques. Adissolvable coating surrounds an orthodontic wire arch form ofsuper-elastic material such as nickel titanium. The predesignedcoated-wire arch form is fixed to the lingual or facial/buccal surfaceof the teeth to be adjusted by flowable composite bead techniques knownin orthodontics. After the composite beads cure and the coatingdissolves, an aperture or tube is left around the wire within thecomposite beads or between the composite and the teeth, allowing thewire to move freely as it returns to its predesigned arch shape, pullingthe teeth into alignment with it. Composite brackets with a lateralgroove adapted to receive a coated-wire arch form aids precisepositioning of the wire on the surface of the teeth. The brackets fitthe contours of teeth and are placed and bonded to teeth in the desiredpositions before application of the arch form. Once in place, the coatedwire is bonded directly to the brackets. These brackets may also have amalleable gel like substance embedded in the lateral groove in which anon-coated wire may be inserted and covered with bonding material. Thesame effect of a tube is formed within the composite bracket when thegel dissolves allowing for the wire to move and align the teeth. Theadaption of the wire to the teeth can be direct or assisted with adelivery system that will hold the wire in position for ease ofapplication to minimize contamination associated with the oralenvironment.

DETAILED DESCRIPTION OF THE INVENTION

The present invention employs wire of the same dimensions and propertiesas the nickel titanium wires used in typical orthodontic treatments,that is, super-elastic metal wires including those of nickel titanium orcopper nickel titanium, beta titanium, and stainless steel. The wiresaccording to the invention are most preferably super-elastic or heatactivated super-elastic wires. The tensile and other physical propertiesof such wires when placed in the required configuration to the teethimpart a force onto the teeth that allow tooth movement to occur withinthe buccal cavity until the point where the desired visual effect isachieved. Preferably according to the invention, wire arch forms arepre-formed in various lengths and gauges to accommodate the needs of avariety of different patients. Though they are called “arch forms”, theactual shape of the pre-formed wire arch forms may not be “arch-shaped”depending on their intended application—for example, a full-mouthlingual arch form would be mushroom shaped. The term “arch form” hereinis used expansively to include any pre-shaped length of wire intended orused to correct a patient's mal-aligned teeth. The pre-shaped wirecorrects improper arch form in a patient's teeth by being placed andbonded to the patient's teeth as shown in FIGS. 4 and 5. The force ofthe now-deformed arch wire working to regain its pre-formed arched shapepushes and pulls the patient's teeth into a shape that conforms to thearch wire, that is, the proper arch form desired. The invention permitsthe wire to slide longitudinally as the arch wire regains its preformedshape, thus preventing undesirable tooth movements created by affixingthe wire to the each tooth a fixed distance apart.

In one embodiment of the invention, the wire is coated with adissolvable coating, preferably a gelatin-like substance such as thegelatin coating used in medicinal liquid gel tablets or a coating havinga lubricating effect such as TiO2 (titanium dioxide). In a preferredembodiment, a coating particularly useful in the invention comprisestitanium dioxide, starch, ethanol and lacquer.

Other dissolvable media that do not hinder the elastic properties of thewire and are safe for the patient may be used.

Coatings operable within the scope of the invention include coatingcurrently available in the dental industry, such as titanium dioxide,polyamide, cellulose derivative, or homopolymer/copolymer ofpoly(ethylene oxide). Other coating operable within the scope of theinvention include substances commonly used in the food and thepharmaceutical industry with materials that render the substance to bedelivered either more easily or pleasantly administered or morepalatable to the consumer. Such coatings include, but are not limitedto: alginates; biopolymers (such as xanthan gum and scleroglucan);carrageenans; galactomannans (such as locust bean gum and guar gum);pectins; native starches (such as products sold under the trademarksAmyloGel@, CreamGel™, DryGel™, Gel™); thinned starches (such as CargillSet™ and Cargill DrySet@); stabilized starches (such as Cargill Tex®,CreamTex@, PolarTex@ and StabiTex@); Pregelatinized starches includingroll-dried starches (such as Cargill Tex¬Instant™, GelInstant™,StabiTex-Instant®, and PolarTex-Instant@) and cold-water swellingstarches such as (HiForm@ and HiForm A™); specialty starches (such asAccuCoat@, AccuFlo™, AraSet™, BatterCrisp®, Clean Set®, DeliTex™,EmCap@, EmTex@, EZ Fi11™, and Salioca@); food additives includingcellulose; microcristalline cellulose; potato; modified wheat starch;talc; finely ground sugar; icing sugar or powder mix, made of icingsugar, starch, fat and flavor; beet or cane sugar; other sweet sugarsolution; fruit juice; honey; caramel; malt; fat; oil; chocolate; cocoapowder; other artificial flavoring; hydrocolloid concentrated solutions(for the purpose of ‘sealing’ the surface to prevent fat migration,harden the surface, offer a smooth surface to the final glazingapplication); alcohol-based solutions of resins, essentially shellacresin (for the purpose of ‘finishing’ the surface to prevent watermigration and reducing friction) and others. A particularly usefulreference is found on the World Wide Web athttp://www.colorcon.com/products-formulation/all-products, the contentsof which are incorporated herein by reference. Other ingredients such asvitamins can be incorporated into the coatings of the invention so as torender additional health benefits to the patient during the time periodthat the patient undergoes treatment with the apparatus and system ofthe invention.

The coating surrounding the wire increases the diameter of the wire tospecific dimensions depending on the size and cross-sectional shape ofthe wire it coats. In one embodiment of the invention, the coating is anoticeably and distinctively different color than the core wire so thatcomplete dissolution of the coating may be easily confirmed visually.

The coated wire arch form is placed directly on the lingual or facial(labial or buccal) surface of the teeth. Activation of the wire iscreated via a pulling force with floss, engagement jigs as shown in FIG.10A, 10B or other means through the contact between the teeth on thecontralateral surface, as shown in FIG. 4. The engagement of the jigs tothe teeth can be accomplished by any means available and the jigs can beengaged on any side of a tooth that would be necessary for the desiredalignment of the teeth. The coated wire is bonded directly to thesurface of the teeth (or to the composite bracket-like templates of analternate embodiment described more fully below) using flowablecomposite material used in conventional orthodontic techniques.

The dental composites operable within the scope of the invention are anydental composite resins typically used in the dental industry, such assynthetic resins which are used in dentistry as restorative material oradhesives. Examples of composite resins most commonly include bisphenolA glycidyl methacrylate (bis-GMA) and other dimethacrylate monomers,such as triethylene glycol dimethacrylate (TEGMA), urethanedimethacrylate (UDMA), hex anediol dimethacrylate (HDDMA), and a fillermaterial such as silica. Dimethylglyoxime is also commonly added toachieve certain physical properties such as flowability. Furthertailoring of physical properties is achieved by formulating uniqueconcentrations and combinations of each constituent.

According to the method of the invention, a “bead” of flowable compositematerial is applied over the coated wire on each tooth to be aligned. Asused herein, the term composite “bead” indicates an application ofcomposite material that is sufficient to attach the wire to the toothsurface. As used herein, the term “bond” or “attach” as referring to thecomposite material used in the system of the invention means that thecomposite material is fixedly connected for some period of time byeither chemical or physical means to the surface of the tooth.

The composites are bonded herein onto the teeth by either light,chemical activation or heat activation as commonly performed in thedental art. In order to bond the composite to a tooth, the tooth must bekept substantially dry during placement or the resin will likely fail toadhere to the tooth. Composites are placed while still in a soft,dough-like, or flowable state but when exposed to light of a certainblue wavelength (typically 470 nm, with traces of ultra-violet light]),they polymerize and harden onto the tooth. Once properly attached, thecomposite is comfortable, aesthetically pleasing, strong and durable,and usually lasts throughout the duration of the treatment without theneed for reapplication. The composite is typically applied to the toothby using a syringe. A primer may be used to allow the composite resin toeasily infiltrate the surface enamel matrix to bond more strongly to thetooth. A photo-initiator is often added to the composite in order to aidand increase the speed of the curing process of the composite. Prior toapplying the composite, the enamel of the teeth may be prepared byetching with 30%-50% phosphoric acid and rinsing thoroughly with waterand drying with air only.

Within 1 to 2 hours after being bonded to the patient's teeth (and afterthe bonding material has cured), the coating surrounding the wiredissolves completely, thus exposing the underlying wire and leaving anaperture or tube within the cured bonding material through which thewire may move freely. By allowing free movement of the now-exposed wirethrough the aperture(s) in the bonding material, the bonding composite“beads” and apertures operate as a tube similar to a “frictionlessbracket system” housing the wire and allowing the now-uncoated wire toexpress its super-elastic properties and pre-designed arch form, pullingand/or pushing the mal-aligned teeth into conformity with it as itreturns to its preformed shape.

Without the apertures or tubes left around the wire by the dissolvedcoating, the wire would not be free to slide back and forth within thecomposite beads as it returns to its preformed shape; thus restricted,the force exerted by the wire returning to its preformed shape alsowould push teeth apart and create space between the teeth or otherundesirable tooth movements or not move the teeth at all. Also to benoted is that the composite beads are not limited to any particularshape or geometric configuration, and are limited in size only as to thepractical consideration of comfort of the patient within the buccalcavity.

As the teeth align and the wire slides within the tubes formed in thecomposite beads, the ends of the wire arch form are pushed farther andfarther beyond the terminal beads. The ends of the wire arch form may becovered with a bead of composite for comfort or, alternatively, may bepre-formed with smooth ends. Once the wire is activated by being bondedto the teeth or templates, stops of composite, crimpable stops or otherstops may be formed or preformed on the arch form ends or between theteeth to prevent the wire arch form from sliding too far and dislodging.As used herein, a “stop” means an element or component positioned on thewire after placement onto the teeth or an element or component that isincorporated into or onto the wire during the fabrication of the wirenot encompassed by the flowable composite during wire placement and hasa larger dimension than the aperture or tube created by the coatingdissolving from the wire. Coated wire arch forms of the system arepreferably pre-formed and pre-shaped in various lengths and gauges(sizes), preferably with smooth ends or terminal beads for patientcomfort and to act as stops. The stops are created or pre-formed on theends or midpoint of the wire arch form so as to prevent the wire fromslipping out of the composite bonding covering or beads when the teethalign. Though preferably the stops are placed on the ends or midpoint ofthe wire arch, the stops may be positioned at any location along thewire arch. The coated arch forms can also be custom shaped for anyindividual and their arch forms.

The wire arch form may be affixed to one or more teeth or templates atthe center of the arch or the longitudinal mid-point of the wire,preferably using a tiny bead of composite or incorporated in the archwire, thus keeping the mid-point of the wire arch form fixed in place(i.e., preventing the wire arch form from sliding out of place) whilepermitting sliding within the composite beads on either side of themid-point as the teeth are pushed and pulled into alignment. A tiny beadof composite is one way the midpoint of the wire arch form can be keptin place, but other ways may be devised. The wire is left in place inthe mouth until it has returned completely or substantially to itsoriginal shape or the teeth are aligned. This typically occurs in 4 to 6weeks, but may require either less or more time depending on the needsof each patient. The wire arch form is removed by removing the stops orby cutting the wire into segments. If further alignment is desired afterthe initial placement and activation, the wire can be re-bonded andactivated on an individual tooth or be replaced by another coated wire.

In one embodiment, a coated wire arch form comprising a substantiallyround wire core having a circular cross-section and a dissolvablecoating of specific and even thickness is used. In another embodiment, acoated wire arch form comprising a square or rectangular wire corehaving a coating of specific and even thickness is used. As used herein,the term “rectangular” as referring to the cross section of the wire ofthe invention shall also encompass embodiments having a square crosssection. The preferred diameter of nickel titanium wire core isgenerally 0.012 inches for round wire core and 0.016×0.022 inches or0.022×0.016 (at its widest diameter) for rectangular wire core. Thecoating surrounding the wire core increases the wire's diameter ascompared to the uncoated wire. The preferable diameter of the coatedwire is enough to create a dimension large enough for the wire to slidein the formed tubes after the coating is dissolved but still staying asthin as possible to allow for the wire to engage the perimeter of theformed tube within the composite bonding surrounding the wire therebycreating the necessary pressure or activation of the wire with a maximumof 0.018 inches for the round wire and 0.018×0.025 inches or 0.025×0.018for the rectangular wire. In all embodiments, a specific outer dimensionof the coated wire may be achieved depending on the choice of wire andthe thickness of the coating. It is preferred that the outer dimensionof the coated wire be only slightly larger than the diameter of the corewire so that engagement of the core wire in the formed tube be adequatefor desired tooth movement yet not interfere with core wire movement.Therefore, it is preferred that the thickness of the coating on the wireis in the range of 0.001 inches to 0.006 inches, such that the totalthickness of the wire together with the coating is in the range of 0.013inches to 0.018 inches.

Where a wire arch of rectangular dimension is used, it is preferred thatthe rectangular wire has a height that is greater than the depth of thewire as the wire is positioned along the teeth, thus keeping within theobjective of the invention in providing an orthodontic appliance with alow in profile within the mouth that is comfortable to the patient, asillustrated in FIGS. 1C and 1D.

In addition the wire, may also incorporate loops 150 or any other shapemodification that may assist in tooth movement, as illustrated in FIG.1E. For example, a loop 150 as part of the wire design, is placedcentrally as in FIG. 1F, or on any part of the lateral extensions as inFIG. 1G. These loops 150 may remain exposed or uncovered by bondingadhesive such that each loop can be activated to assist in space closuremovements by activation of the terminal ends of the wire. The terminalend of the wire which is beyond or most distal to the loop on eitherside of the wire is removed from the bonding material which has securedit in position. The wire is then extended thereby opening the loop andgenerating force with the wire. The extended terminal end of the wirecan then be re-bonded to the tooth surface. This causes any spacebetween the teeth to close due to the force generated between the loopsof the wire.

According to another embodiment of the invention, composite bracketswith a lateral or horizontal groove are provided that are adapted toreceive the coated-wire arch form, which are used as an alternative tothe composite beads to assist with precise positioning of the wire onthe surface of the teeth. The composite brackets preferably are made tofit the contours of the lingual or facial surface of teeth and areplaced and bonded to the teeth in the desired positions beforeapplication of the coated wire arch form. The bonding or attachment tothe teeth is accomplished in the same manner as the composite beads asdescribed hereinabove. Once in place, the coated wire arch form isbonded directly to the bracket. The brackets' grooves may bespecifically shaped to effect a pre-programmed torque adjustment(correcting mal-alignment of a tooth's cant or rotation along thelabial/lingual or buccal/lingual axis) when used in the system.Preferably, in this torque-adjusting embodiment, bracket grooves haveone of a variety of specific rectangular cross-sectional shapescorresponding to the desired torque adjustment, adapted to be used witha pre-shaped arch form of wire with a rectangular cross-section. Thesebrackets may also be used in the continuation of treatment if furtheractivations or increased engagement of the orthodontic wire is necessaryto align the teeth. At subsequent visits, any tooth which requiresfurther activation can be reactivated by removing the existing bondedcovering of the wire. The direct application of bonding material locksthe now non-coated wire and inhibits wire movement due to lack of tubeformation. The open end of the bracket can be placed over the wireagainst the tooth while the wire is reactivated by an external force(floss or other engagement module). The extensions of the brackets maybe coated with a thin layer of composite/bonding material or dentaladhesive to help secure the bracket in position. Though a compositecovering is preferred and is the logical choice based on industrypractice, the covering can be made of an alternate functioning material.Flowable bonding material then covers the existing bracket except in theareas of the lateral openings extending over the surface area of thetooth securing the bracket in position. The opening within the bracketacts as an orthodontic tube and allows for the expression of the archwire to align the teeth. Additionally, an embodiment may contain agroove or slot coated by a metal that is then secured by a compositecovering.

In addition to this embodiment, the grooves of the bracket can beprefilled with a dissolvable gel or malleable substance, as illustratedin FIGS. 2B and 2C, into which the non-coated wire is inserted. The gelenvelopes the wire within the groove or slot of the bracket, as shown inFIGS. 2D and 2E). While engaging the wire into the slot, the exposedarea of the slot is covered with a bead of composite securing the wirein the slot of the bracket (FIG. 2F). The gel-like substance within thegroove of the bracket dissolves creating the necessary tube in which thewire can move so as to align the teeth (FIG. 2G). This embodiment canalso be used in subsequent appointments for continued tooth movement andalignment of individual teeth after the initial placement of the coatedwire.

The gels operable in this embodiment of the invention comprise agar,agar agar, carrageenan iota, carrageenan kappa, gellan gum, lecithinpowder or gel, pectin powder or gel, sodium alginate, xanthan gum, aswell as other compounds known in the art and interchangeable therewith.As used herein, these and other substances that are operable within thescope of the invention are referred to herein as the “gel”.

In addition the dissolvable gel may be applied directly to the toothsurface via syringe or other type of applicator while the now non-coatedwire is positioned against the tooth (see FIG. 12.) The gel preferablycovers only the area immediately surrounding the wire to minimize theresulting size of tube formation. The wire and gel are covered withcomposite bonding material and extended over the exposed surface area ofthe tooth securing the wire into position. As describe above, the gellike substance dissolves and creates a tube within the compositematerial allowing the nickel titanium wire to express its pre-designedshaped and align the teeth.

In addition to the direct placement of the wire, the system of inventionmay also be placed into the mouth with a delivery system for ease ofengagement and in order to minimize contamination from the oralenvironment. This system is comprised of a custom tray that isspecifically fitted to the teeth and mouth of each patient, in which thecoated wire is housed and positioned for proper placement, asillustrated in FIG. 10A. The delivery tray may be composed of plastic orany other materials used in the industry for production of dental trays.The coated wire has the elastic engagement jigs attached and positionedas in FIG. 11. The engagement jigs can be threaded between the teethactivating the wire. The terminal ends of the wire within the plastictray housing are free to move within the lateral tubes of the housingthus allowing the engagement of the wire to the teeth withoutresistance. The tubes within the housing should be long enough toprevent the wires from separating and dislodging away from the deliverytray. Once the active part of the wire has been engaged and attach tothe lingual surface of the teeth, the delivery system is removed bycutting the arch wire at the terminal beads of composite and cuttingeach individual engagement jig at the surface of the coated wire.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of processes, steps, orconstruction, or to the arrangements of the components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein are for the purpose of description andshould not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception,upon which this disclosure is based, may readily be utilized as a basisfor the designing of other structures, methods, and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

DESCRIPTION OF THE DRAWINGS

FIG. 1A—Perspective view of two different embodiments of the coated wirearch form of the invention, one with a round cross-section and one witha rectangular cross section.

FIG. 1B—Cross-sectional view of the two embodiments of the coated wirearch form depicted in FIG. 1A.

FIG. 1C—Longitudinal view of the coated rectangular wire showing thedimension of the wire being greater in height than width.

FIG. 1D—Cross sectional view of the embodiment of FIG. 1C withrectangular measurements greater in height than width.

FIG. 1E—Occlusal view of the maxillary arch of the mouth of a patientshowing an embodiment of the wire according to the invention withbilateral loop formations in it design.

FIG. 1F—A view of one embodiment of the wire according to the inventionshowing an individual arch form with a centrally located loop.

FIG. 1G—A view of an alternate embodiment of the wire according to theinvention showing an individual arch form with loops as part of itsdesign located on its lateral extensions as illustrated in FIG. 1E.

FIG. 2—Front elevational view of a composite bracket of one embodimentof the invention, said bracket having a lateral groove to hold thecoated orthodontic wire in the desired position before bonding.

FIG. 2A—Side view of the composite bracket of FIG. 2.

FIG. 2B—Frontal view of the embodiment showing the gel positioned in thegroove of the bracket.

FIG. 2C—Cross-sectional view of the embodiment showing the gel withinthe groove of the bracket.

FIG. 2D—Frontal and cross-sectional view of the bracket with the gelwithin the groove and non-coated core wire outside of the bracketgroove.

FIG. 2E—Frontal and cross-sectional view of the bracket with non-coatedcore wire inserted into the gel.

FIG. 2F—Frontal and cross-sectional view of the bracket and wire withthe composite bead covering the open area of the groove locking the wirein place within the gel.

FIG. 2G—Frontal and cross-sectional view of the bracket with non-coatedcore wire and composite bead. The gel has dissolved and created anaperture or tube around the wire.

FIG. 3—Occlusal view of a maxillary arch showing mal-alignment of theanterior teeth.

FIG. 4—Occlusal view of the maxillary arch of FIG. 3 with the coatedorthodontic wire pulled into position via floss in contact with thelingual surface of the maxillary anterior teeth to be aligned.

FIG. 5—Occlusal view of the maxillary arch and orthodontic wire of FIG.4 with composite beads placed on the individual teeth covering the wire.

FIG. 6A—Occlusal view of the maxillary arch, orthodontic wire andcomposite beads of FIG. 5 showing the orthodontic wire after the coatinghas dissolved.

FIG. 6B—Cross-sectional view of a composite bead showing the apertureleft after dissolution of the wire's coating.

FIG. 7—Occlusal view of the maxillary arch, orthodontic wire andcomposite bead of FIG. 6A showing the wire after its return to itspreformed shape and showing the anterior teeth in proper alignment.

FIG. 8—Occlusal view of a maxillary arch showing placement of compositebrackets on the lingual surface of anterior teeth to aid in preciseplacement of the coated orthodontic wire arch form before bonding.

FIG. 9—Occlusal view of the maxillary arch showing placement of adelivery tray to assist in the placement of the invention. The traycovers the posterior portion of the arch and is open in the anteriorsegment in the area of wire delivery. The wire arch form is held inplace by “micro tube housing” which allows the wire to slide intoposition.

FIG. 10A—Occlusal view of the maxillary arch showing arch wirepositioned within a delivery tray with engagement jigs attached to thesurface of the coated portion of the arch wire.

FIG. 10B—Top and side close-up view of engagement jigs showing detailsof its structure and components.

FIG. 11—Occlusal view of the maxillary arch showing wire engagementagainst the teeth utilizing the delivery tray and engagement jigs.

FIG. 12—Occlusal view of the maxillary arch with the orthodontic wire ofthe invention showing application with a syringe of the gel onto atooth.

FIG. 13—Occlusal view of the maxillary arch showing the compositebonding over dissolvable gel coating.

FIG. 14—Occlusal view of the maxillary arch showing an aperture or tubeformation under a composite bead.

FIG. 15—A perspective view of a tooth together with a composite brackethaving a groove facing the surface of the tooth and the compositebracket having a thin layer of composite material or dental adhesive forattaching to the tooth.

FIG. 16—A perspective view of the tooth and composite bracket of FIG. 15wherein the bracket is bonded to the tooth and showing a roundcross-section of the arch wire of the invention within the groove of thebracket.

It should be understood that the above described figures are notintended to limit the scope of the present invention in any way and areintended to illustrate the embodiments of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1A, two embodiments of the wire arch form of theinvention are shown. The coated round orthodontic arch form 100comprises a round wire core 30, preferably of nickel titanium,substantially coated at a substantially even thickness with a non-toxiccoating adapted to dissolve upon prolonged (preferably no less than 1hour) exposure to moisture, heat, oral fluids or any combinationthereof. An alternate embodiment uses an arch form with a rectangularcross-section 100. The coated rectangular orthodontic arch formcomprises a rectangular wire core 30, preferably of nickel titanium,substantially coated at a substantially even thickness with a non-toxiccoating adapted to dissolve upon prolonged (preferably no less than 1hour) exposure to moisture, heat, oral fluids or any combinationthereof. Alternatively, the coating is a substance that withstandsprolonged exposure to moisture, heat and oral fluids but readilydissolves upon contact with a non-toxic triggering solution. In allcases, the coating should not interfere with the super-elasticproperties of the pre-formed arch wire and should be non-toxic andsubstantially non-irritating.

The wire core 30, is preferably nickel titanium, but wire made of anymetal or other material with similar super-elastic properties, includingcopper NiTi (copper-zinc-aluminum-nickel, copper-aluminum-nickel),Sentalloy®, Neo Sentalloy® and Bioforce® wires or any othersuper-elastic wires or wires with ion-implantation process, may be used.

The round wire core 30 has a preferred diameter of 0.012 inches, but around core having a diameter from 0.010 inches to 0.017 inches isoperable. The cross-section of the rectangular wire core 30 of theinvention can be in the range of 0.012 inches to 0.022 inches. Therectangular core 30 has a preferred diameter of 0.012×0.018 inches, buta rectangular core having a diameter from 0.012×0.018 inches to0.016×0.022 inches is also operable within the scope of the invention.

FIG. 1B shows the dissolvable non-toxic coating 20, which is preferablycomposed substantially of gelatin or any non-toxic dissolvable coatingwith lubricating properties like titanium dioxide (TiO2), similar tothat used to coat tablets and form capsules for oral medicinal use, suchas Kollicoat® (available from BASF), but any non-toxic dissolvablecoating which does not interfere with the super-elastic properties ofthe wire core 30, may be used. Because the dissolvable coatingsubstantially coats the wire core at a substantially even thicknessaround and along the wire core 30, the dissolvable coating conforms tothe shape of the wire core, increasing its diameter without altering itscross-sectional or longitudinal shape. The preferable diameter of thecoated wire arch form is 0.018 inches, but a diameter as low as 0.012and preferably in the range of 0.013 inches to 0.018 inches is operable,it being understood that the diameter of the coated wire depends on thediameter of the wire core.

Referring now to FIG. 1B, cross sections of the round coated wire archform 100 and rectangular coated wire arch form 100 are shown. Referringto the depiction of arch form 100, the rectangular wire core 30 anddissolvable coating 20 of substantially even thickness is shown incross-section. Referring to the depiction of arch form 100, the roundwire core 30 and dissolvable coating 10 of substantially even thicknessis shown in cross-section. Referring to FIG. 1C, the longitudinal viewof the rectangular core wire 30 wherein the height of wire is greaterthan its depth. FIG. 1D is a cross-sectional view of the core wire 30with coating 20.

Referring now to FIG. 2, a front elevational view of the compositebracket embodiment of the invention is shown. The composite bracket 300assists with the precise positioning of the orthodontic wire 100 on thesurface of teeth before the wire arch form is bonded to the teeth.Preferably, composite bracket 300 conforms to the contours of the toothto which it will be applied, and generally has a top edge 50 and abottom edge 60. In one embodiment, the top edge 60 and bottom edge 50are substantially parallel, but the exact shape of each compositebracket will vary as each is designed to fit the specific contours ofindividual teeth. Each composite bracket 300 has a lateral groove 55 inits surface 70 extending substantially across its entire width adaptedto hold the coated orthodontic wire arch form in place for bonding.Preferably, the groove 55 bisects the bracket widthwise at substantiallyits midpoint.

Each composite bracket 300 is placed where desired and bonded to theteeth, before application of the wire arch form, using known orthodonticbonding techniques, such that the grooves in each bracket align to forma guide for proper placement of the arch form. The grooves 55 areadapted to hold a coated orthodontic wire arch form 100 in place bybeing of sufficient depth and diameter and sufficiently conforming shapethat the arch form 100 is movably captured with enough friction fit toresist slipping or falling but not so tightly that the arch form cannotbe easily adjusted during placement. The optimal dimensions of thegrooves 55 are 0.018 inches deep and 0.018 inches in diameter measuredat the surface of the bracket as shown in FIG. 2A. As illustrated on theFIG. 2A, the diameter of the groove is the distance measured from pointa to point b along the plane of the bracket's surface. Once in place,the orthodontic wire arch form is bonded to each composite bracket 300using flowable composite beads as described herein.

FIGS. 2B (frontal view) and 2C (cross-sectional view) show thedissolvable gel 65 held within the lateral groove 55 of bracket 300.Lateral groove 55 has a preferred width of 0.013-0.018 inches. FIG. 2Dshows a non-coated wire 30 prior to placement into lateral groove 55.FIG. 2E shows the non-coated wire inserted into the gel 65 and thelateral groove 55. FIG. 2F shows placement of the composite covering 801over the exposed groove area of the bracket holding the wire in placewithin the gel 65 and lateral groove 55, which is held in place bycovering 801. FIG. 2G shows the formation of the aperture or tube 800within the bracket by the dissolved gel 65. The core wire 30 is nowcapable of movement within the bracket 300. This feature of theembodiment allows for the non-coated core wires 30 to be placed in thebracket and the tube formation to be within the bracket when the gelwithin the lateral groove 55 has dissolved.

These gel filled brackets can be used at the initiation of treatmentusing multiple brackets or singularly at subsequent appointments toreactivate individual teeth after the core wire has been exposed.

FIGS. 3-5 depict the occlusal view of a maxillary arch 500 showingmal-alignment of the anterior teeth, specifically the front-rightincisor 505. FIG. 4 shows the application of the coated wire arch formaccording to the invention to the lingual surface of the teeth of FIG.3. The system and method may alternatively be used to apply the archform to the facial surface of teeth. Likewise, use of the system andmethod to correct mal-aligned of maxillary teeth is shown, but thesystem and method may alternatively be used to correct misalignedmandibular teeth as well. Referring now to FIG. 4, floss 600 is wrappedaround the coated orthodontic wire arch form 100 between the teeth toplace the coated wire arch form into the desired position on the lingualsurface of the anterior teeth 700 and to pull the arch form tightlybetween each piece of floss to increase contact of the coated wire tothe surface of the teeth.

Demonstrated in FIG. 5, the coated wire arch form 100 is secured to thelingual surface of the anterior teeth via composite beads 801, 802, 803,804 of flowable composite material using known orthodontic techniques.Preferably, left end 80 and right end 90 of the coated wire arch form100 extend past the terminal composite beads 801 and 804, respectively.The optimal distance of extension beyond each terminal composite beadwhen applied is preferably in the range from 1 mm to 2 mm.

FIGS. 6A and 6B depict the wire arch form after the coating hasdissolved. Only the wire core 30, will remain, leaving an aperture ortube 800 (shown in FIG. 6A) in the composite bead 801, 802, 803, 804.The exposed ends of the wire arch form may be covered by beads ofcomposite for comfort, (bead 80 shown on left end of wire and right endbead 90 is shown on the right end of the wire). Alternatively, the wirearch form may have prefabricated smooth ends.

Over the course of a period of time (in the range of 4 weeks to 8 weeks,depending on the patient), the now-uncoated wire arch form 30 returns toits preformed shape, pulling teeth into alignment with it. Referring nowto FIG. 7, the maxillary arch of FIG. 6B is shown after the uncoatedwire arch form 30 has returned to its preformed shape and themal-alignment in the right incisor 505 has been corrected. The ends ofthe arch form, with terminal beads 80, 90 for comfort, are shownextended a greater distance beyond their position of FIG. 6B, as theforce exerted by the wire arch returning to its preformed shape haspushed the ends of the wire further beyond the terminal composite beads,due to free movement of the wire within the apertures of the compositebeads, instead of pushing the teeth apart. Wire stops or composite beadsmay be applied to the terminal ends of the wire arch form or between theteeth to prevent the wire arch form from dislodging.

Referring now to FIG. 8, an alternate embodiment of the system andmethod is partially shown. Brackets 300 preferably made of orthodonticcomposite material are shaped to conform to the contours of specificteeth and have a lateral groove 55 extending across their widthspreferably bisecting them at substantially their midpoints. The bracketsenable precise positioning of the coated wire arch form before it isbonded. Brackets may be made with grooves 55 or notches of one of avariety of particular, pre-programmed shapes, preferably rectangularshapes, adapted to cause a desired torque adjustment on a particulartooth or teeth when used with the system and in particular with thepre-shaped arch forms of the invention, preferably those having arectangular cross-section. Brackets are first placed and bonded to thelingual or facial surface of the teeth using known orthodontictechniques such that their grooves align to form the desired placementof the coated wire arch form. The grooves of the brackets may beprotected with a removable covering to prevent excess bonding materialfrom blocking or filling the grooves, which covering is then removedonce the brackets are in place and bonded to the surface of the teeth.The grooves may also be filled with a dissolvable and malleable gel 65(FIG. 2E) in which a non-coated wire is inserted into the gel whichcoalesces around the wire (FIG. 2F). FIG. 15 illustrates a close upperspective view of one tooth together with a composite bracket of FIG.8, showing lateral groove 55 facing the surface of the tooth and thecomposite bracket 300 having a thin layer of composite material ordental adhesive 340 for attaching to the tooth. FIG. 16 furtherillustrates a perspective view of the tooth and composite bracket ofFIG. 15 wherein bracket 300 is bonded to the tooth and shows a roundcross-sectional arch wire 30 within the groove 55 of the bracket.

The coated wire arch form is placed in position and movably held thereby friction fit with the brackets' grooves or by force generated againstthe wire via floss or other form of engagement jig (FIG. 10A) asdescribed above, or by alternative means of force to position the wirein the bracket groove and hold it there while it is being bonded inplace. The dimensions of the brackets' grooves correspond to thedimensions of the coated wire arch form, preferably sufficiently to holdthe coated wire arch form in place but not hold it so tightly that thearch form may not be easily adjusted before bonding. Once the coatedwire arch form is in position and held there by friction fit, pullingforce via floss or other external force, the coated wire arch form isbonded in place using beads of flowable composite as in FIG. 5, exceptthat instead of being bonded to the surface of the teeth as in FIGS. 5and 6, the coated wire arch form is bonded to the brackets (which havealready been bonded to the surface of the teeth as previouslydescribed). Thus, in the embodiment making use of brackets as partiallyillustrated in FIG. 8, each aperture left after dissolution of thecoating, if not entirely within a composite bead, is between thecomposite bead and the bracket (particularly the groove of the bracket),rather than between the composite bead and the surface of the tooth, asin the embodiment without brackets partially illustrated in FIGS. 5 and6.

FIG. 12 illustrates the occlusal view of the maxillary arch with theorthodontic wire of the invention 30 showing application with a syringe750 of the gel 65 onto a tooth. FIG. 13 illustrates the occlusal view ofthe maxillary arch with an embodiment showing the orthodontic wire ofthe invention showing a bead of composite covering the wire and gel andattached to the tooth. The application of the gel with the syringe isparticularly useful as part of the process of the invention for followup appointments after initial placement of the wire in order tore-activate individual teeth. FIG. 14 illustrates the occlusal view ofthe maxillary arch with the orthodontic wire of the invention showing abead of composite covering the wire wherein the gel has dissolved andcreated a tube or aperture under the composite bead surrounding theorthodontic wire.

Referring now to FIG. 9, illustrated is a method delivering the systemof the invention to the teeth and mouth in order to help position anddeliver the wire to an individual patient with ease and control. Themethod provides a delivery tray 900 which is custom made to athree-dimensional model representation of the patient's arch 500. Tray900 has specifically positioned “micro tube housing’ 950 on both sidesof the tray holding and securing the arch wire to the teeth. The coatedportion of the wire 100 is positioned in the open portion of the tray900 in the area for which it is adhered to the teeth. The non-coatedcore wire extensions 30 are engaged in the “micro tube housing” 950holding the wire in its position. The “micro tube housing” 950 ispreferably long enough to hold an extension of the core wire 30 in whichthe wire can slide through the micro tube housing 950 withoutdislodging.

FIG. 10B illustrates another component of the delivery system whichincorporate engagement jigs (shown in FIG. 10A) which are attached tothe main wire and positioned between each contact 901-907. Theseengagement jigs are made of an elastic material preferably, such as,silicone or rubber like materials in which the jig can be stretched andthreaded between the contacts of the teeth pulling the wire intoposition and securing the wire while being bonded to the tooth surfaceas illustrated in FIG. 11. Once the wire is bonded in place, theindividual jigs may be removed by pulling on the smaller extension awayfrom the wire and trimming with a cutting instrument. The remainder ofthe delivery tray can be removed after trimming the wire at the terminalcomposite beads.

One of ordinary skill understands that a “tooth” can be natural orartificial (such as a crown or an implant, or filled with compositematerial, etc.).

It is to be understood that the present invention is not limited to theembodiments described above or as shown in the attached figures, butencompasses any and all embodiments within the spirit of the invention.

1. An apparatus for orthodontic wire alignment, comprising: a wirecoated with a dissolvable coating; a flowable composite material that atleast partially surrounds the wire coated with the dissolvable coating;wherein the flowable composite material is in contact with a tooth. 2.Apparatus according to claim 1, wherein the flowable composite materialis adapted to harden to attach the flowable composite material to thetooth.
 3. Apparatus according to claim 1, wherein the composite materialis on the dissolvable coating.
 4. Apparatus according to claim 3,wherein after the dissolvable coating dissolves, a gap remains betweenthe wire and the composite material so that the wire is in an apertureformed by the composite material.
 5. Apparatus according to claim 1,wherein the tooth is one of a plurality of teeth, and the compositematerial is in contact with the plurality of teeth.
 6. Apparatusaccording to claim 5, wherein the wire applies force to the plurality ofteeth.
 7. Apparatus according to claim 4, wherein the tooth is one of aplurality of teeth, the composite material applies force to theplurality of teeth, and the wire is permitted to move within theaperture and along the plurality of teeth.
 8. Apparatus according toclaim 1, wherein the flowable composite material is in contact with alingual surface of the tooth.
 9. Apparatus according to claim 1, whereinthe wire comprises at least one of nickel titanium and stainless steel.10. Apparatus according to claim 1, wherein the composite material is acomposite resin.
 11. Apparatus according to claim 1, wherein thecomposite is selected from the group consisting of bisphenol A glycidylmethacrylate 9bis-GMA) and other dimethacrylate monomers, such astriethylene glycol dimethacrylat (TEGMA), urethane dimethacrylate(UDMA), and hexanedio dimethacrylate (HDDMA), silica anddimethylglyoxime.
 12. Apparatus according to claim 1, wherein the wireis also in contact with the tooth.
 13. Apparatus according to claim 1,wherein the composite material is between the wire and the tooth.
 14. Amethod of aligning a plurality of teeth, said method comprising thesteps of: a) providing the apparatus of claim 1, wherein the tooth isone of said teeth; and b) allowing the dissolvable coating to dissolve.15. A method of aligning a plurality of teeth, said method comprisingthe steps of: providing: a wire coated with a dissolvable coating; aflowable composite material that at least partially surrounds the wirecoated with the dissolvable coating; wherein the flowable compositematerial is in contact with the teeth; and allowing the dissolvablecoating to dissolve.